Sr. Drug Safety Specialist at GE Healthcare

Shanghai, Shanghai, China

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Technology, PharmaceuticalsIndustries

Requirements

Minimum of 3 years in pharmaceutical/biotechnology industry with experience in Pharmacovigilance including clinical trials and post-marketing
Proficient in all aspects of case processing, including case assessment (seriousness, expectedness, reportability), narrative writing, MedDRA coding, quality review, expedited report review and scheduling, and follow-up with reporters
Strong understanding of Safety Database functionality and business workflow to be able to perform root cause analyses and troubleshoot
Confidence in decision-making, taking into consideration data handling conventions, but also industry expectations and regulations
Strong working knowledge of US/EU/AP/LA regulations and ICH guidelines
Demonstrated ability to train and coach PV personnel
Demonstrated ability to manage own workload, prioritize, plan and organize assignments and work within strict timelines
Understanding of Microsoft (tools implied, e.g., Office suite)

Responsibilities

Receive, triage and process adverse event and medical device reports from all sources including post-marketing, clinical trials and published literature
Perform initial assessment of seriousness, expectedness, causality, and reportability in accordance with GPV processes and global regulatory requirements and guidelines
Perform data entry and quality review of adverse event reports into the global safety database, including accurate coding of MedDRA terms and preparation of case narratives
Identify missing or discrepant information and perform active case follow-up via verbal or written contact
Review expedited reports for submission to regulatory authorities and ethics committees
Serve as pharmacovigilance liaison and resource to internal and external groups (e.g., Regulatory Affairs, Medical Affairs, Quality Assurance, clinical development teams, CROs, etc.)
Perform reconciliations between clinical, quality and PV databases
Support safety physicians in handling issues related to both clinical and post-marketing safety, as needed
Support preparation and submission of aggregate reports including PSURs, DSURs, and US Periodic Reports, as needed
Serve as pharmacovigilance resource and subject matter expert during inspections and audits
Vendor oversight as needed, collaborating with external project leaders and teams to develop solutions, provide appropriate training, and monitor quality
Provide oversight of clinical trials, requesting study configurations and developing study-specific job aids, as needed
Oversee workflow management and case prioritization to maintain compliance with regulatory timelines
Provide Compliance group with root cause analysis and CAPA for late submissions
Troubleshoot questions and issues with team, including database functionality, case processing conventions, and report submission failures; provide guidance based on experience and Data Handling Conventions
Assist with writing and updating of SOPs and other guidance documents, in response to process improvements or changing regulations
Participate in database projects and user acceptance testing, as needed, providing insight from business user / case processing perspective

Skills

Pharmacovigilance

ICSR Processing

MedDRA Coding

Adverse Event Reporting

GPV Processes

Regulatory Submissions

PSURs

DSURs

Safety Database Management

Case Follow-up

Causality Assessment

Data Reconciliation

GE Healthcare

Healthcare technology and data analytics provider

About GE Healthcare

GE Healthcare provides a range of healthcare technologies and services aimed at improving patient care. Its main products include imaging systems, mobile diagnostic devices, patient monitoring solutions, and advanced software for data analysis. These products help medical professionals make informed decisions and enhance the efficiency of healthcare delivery. Unlike many competitors, GE Healthcare invests significantly in research and development, allocating $1 billion each year to innovate and enhance its offerings. The company’s goal is to support healthcare providers in delivering better patient outcomes, as evidenced by its technology supporting over 300,000 patients daily and managing 2 billion patient scans each year.

Chicago, IllinoisHeadquarters

1892Year Founded

N/ACompany Stage

Data & Analytics, HealthcareIndustries

10,001+Employees